Methods of providing weight loss therapy in patients with major depression

Abstract

Disclosed are methods of providing weight loss therapy, particularly for patients suffering from major depression.

What is claimed is: 
     
       1. A method for reducing symptoms of depression by at least 40% in an obese or overweight patient, comprising:
 selecting a patient who is suffering from major depressive disorder who is overweight or obese; and 
 reducing symptoms of depression of the patient by at least 40% by administering to the patient a pharmaceutical composition comprising naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof, wherein the daily dose of naltrexone is about 4 mg to about 50 mg per day and the daily dose of bupropion is about 30 mg to about 500 mg. 
 
     
     
       2. The method of  claim 1 , wherein naltrexone or pharmaceutically acceptable salt thereof is administered about 32 mg per day and bupropion or pharmaceutically acceptable salt thereof is administered about 360 mg per day. 
     
     
       3. The method of  claim 1 , wherein the naltrexone or a pharmaceutically acceptable salt thereof and bupropion or a pharmaceutically acceptable salt thereof is administered more than once per day. 
     
     
       4. The method of  claim 1 , wherein the naltrexone or pharmaceutically acceptable salt thereof is administered prior to or subsequent to the bupropion or pharmaceutically acceptable salt thereof. 
     
     
       5. The method of  claim 1 , wherein the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof are in a single oral dosage form. 
     
     
       6. The method of  claim 1 , wherein the daily dose of the naltrexone or pharmaceutically acceptable salt thereof is escalated from 8 mg in week one to 16 mg in week two, 24 mg in week three, and 32 mg in week four and thereafter; and wherein the daily dose of the bupropion or pharmaceutically acceptable salt thereof is escalated from 90 mg in week one to 180 mg in week two, 270 mg in week three, and 360 mg in week four and thereafter. 
     
     
       7. The method of  claim 1 , wherein at least one of naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation. 
     
     
       8. The method of  claim 1 , wherein each of the naltrexone or pharmaceutically acceptable salt thereof and bupropion or pharmaceutically acceptable salt thereof is in a sustained release formulation. 
     
     
       9. The method of  claim 1 , wherein the patient is overweight. 
     
     
       10. The method of  claim 1 , wherein the patient is obese. 
     
     
       11. The method of  claim 1 , wherein the pharmaceutical composition consists essentially of the naltrexone or pharmaceutically acceptable salt thereof and the bupropion or pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, diluent, or carrier. 
     
     
       12. The method of  claim 1 , wherein the reduction in symptoms of depression is measured using Montgomery-Åsberg Depression Rating Scale. 
     
     
       13. The method of  claim 1 , wherein the reduction in symptoms of depression is measured using the Inventory of Depressive Symptomatology. 
     
     
       14. The method of  claim 1 , wherein the reduction in symptoms of depression is at least about 60%. 
     
     
       15. The method of  claim 1 , wherein the pharmaceutical composition is administered to the patient for a period of at least 12 weeks. 
     
     
       16. The method of  claim 1 , wherein the pharmaceutical composition is administered to the patient for a period of at least 24 weeks. 
     
     
       17. The method of  claim 1 , wherein the patient has a body mass index (MBI) of at least 27 kg/m 2  and an Inventory of Depressive Symptomatology-Self Report (IDS-SR) total score of at least 26 prior to initiating administration of the pharmaceutical composition.